ID

40873

Descrizione

Study ID: 101468/902 Clinical Study ID: 101468/902 Study Title:A study to evaluate the effect of repeated oral doses of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram compared to placebo and single oral doses of moxifloxacin (Bayer) as a positive control. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Phase: Phase 1 Study Recruitment Status: Completed Generic Name: ropinirole Trade Name: Modutab,ZIPEREVE,ZEPREVE,REPREVE,ADARTREL,REQUIP,Zygara; Zygara,ZIPEREVE,ZEPREVE,Requip Depot,REQUIP,REPREVE,Modutab,ADARTREL Study Indication: Restless Legs Syndrome

Keywords

versioni (1)
  1. 29/05/20 29/05/20 -
Titolare del copyright

GlaxoSmithKline

Caricato su

29 maggio 2020

DOI

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Licenza

Creative Commons BY-NC 4.0
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Effect of ropinirole on cardiac conduction as assessed by 12-lead electrocardiogram (101468/902)

Inglese

Drug Tolerance; Dose Details

1 moduli  
Administrative
Descrizione

Administrative

Alias
UMLS CUI-1
C1320722
Subject Number
Descrizione

Subject Number

Tipo di dati

text

Alias
UMLS CUI [1]
C2348585
Drug Tolerance
Descrizione

Drug Tolerance

Alias
UMLS CUI-1
C0013220
Did the patient tolerate 0.125mg/0.25mg?
Descrizione

Did the patient tolerate 0.125mg/0.25mg?

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0013220
If patient did not tolerate the dose, enter the reason why
Descrizione

If patient did not tolerate the dose, enter the reason why

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0013220
UMLS CUI [1,2]
C0566251
In the Investigator’s opinion, is it safe for the subject to increase to the next dose level?
Descrizione

Y - Subject will receive the next dose level. N - Select a dosing strategy from the options below and tick the relevant box:

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1735338
UMLS CUI [1,2]
C1113679
If it is not safe for the subject to increase to the next dose level, select a dosing strategy from the options below and tick the relevant box:
Descrizione

If it is not safe for the subject to increase to the next dose level, select a dosing strategy from the options below and tick the relevant box:

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C1735338
UMLS CUI [1,2]
C1113679
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C0679199
Dose Details
Descrizione

Dose Details

Alias
UMLS CUI-1
C0678766
UMLS CUI-2
C1522508
Dose to be attempted:
Descrizione

Dose to be attempted:

Tipo di dati

integer

Unità di misura
  • mg
Alias
UMLS CUI [1]
C3174092
mg
Dose Level Attempt:
Descrizione

Dose Level Attempt:

Tipo di dati

integer

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0441889
Dose Details - Comments
Descrizione

Dose Details - Comments

Tipo di dati

text

Alias
UMLS CUI [1,1]
C0678766
UMLS CUI [1,2]
C1522508
UMLS CUI [1,3]
C0947611
Dose checked and administered by:
Descrizione

Dose checked and administered by:

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1283174
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C2348343
Dose checked and witnessed by:
Descrizione

Dose checked and witnessed by:

Tipo di dati

text

Alias
UMLS CUI [1,1]
C1283174
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0682356
UMLS CUI [1,4]
C0178602
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Similar models

Drug Tolerance; Dose Details

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
Administrative
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item Group
Drug Tolerance
C0013220 (UMLS CUI-1)
Did the patient tolerate 0.125mg/0.25mg?
Item
Did the patient tolerate 0.125mg/0.25mg?
boolean
C0013220 (UMLS CUI [1])
If patient did not tolerate the dose, enter the reason why
Item
If patient did not tolerate the dose, enter the reason why
text
C0013220 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
In the Investigator’s opinion, is it safe for the subject to increase to the next dose level?
Item
In the Investigator’s opinion, is it safe for the subject to increase to the next dose level?
boolean
C1735338 (UMLS CUI [1,1])
C1113679 (UMLS CUI [1,2])
Item
If it is not safe for the subject to increase to the next dose level, select a dosing strategy from the options below and tick the relevant box:
integer
C1735338 (UMLS CUI [1,1])
C1113679 (UMLS CUI [1,2])
C0178602 (UMLS CUI [2,1])
C0679199 (UMLS CUI [2,2])
If it is not safe for the subject to increase to the next dose level, select a dosing strategy from the options below and tick the relevant box:
Code List
If it is not safe for the subject to increase to the next dose level, select a dosing strategy from the options below and tick the relevant box:
CL Item
Dose reduce to the dose level below (return to the previous dose level) for a further 1-4 days of dosing at the (1)
CL Item
lower dose level. (2)
CL Item
Administer domperidone to reduce adverse events. ONLY IF THIS IS A SECOND ATTEMPT AT THIS DOSE (3)
CL Item
LEVEL. (4)
CL Item
The investigator decides that the subject has reached their MTD. (5)
Item Group
Dose Details
C0678766 (UMLS CUI-1)
C1522508 (UMLS CUI-2)
Dose to be attempted:
Item
Dose to be attempted:
integer
C3174092 (UMLS CUI [1])
Dose Level Attempt:
Item
Dose Level Attempt:
integer
C3174092 (UMLS CUI [1,1])
C0441889 (UMLS CUI [1,2])
Dose Details - Comments
Item
Dose Details - Comments
text
C0678766 (UMLS CUI [1,1])
C1522508 (UMLS CUI [1,2])
C0947611 (UMLS CUI [1,3])
Dose checked and administered by:
Item
Dose checked and administered by:
text
C1283174 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C2348343 (UMLS CUI [1,3])
Dose checked and witnessed by:
Item
Dose checked and witnessed by:
text
C1283174 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0682356 (UMLS CUI [1,3])
C0178602 (UMLS CUI [1,4])
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